Brand
Brainlab Ag Recalls
27 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Brainlab Ag.
27Total Recalls
2Critical
7,209Units Affected
Feb 10, 2025Most Recent
All Recalls
Every Brainlab Ag Recall
Sorted by most recent. Click any recall for full details.
27 recalls
High RiskFDA
Brainlab Ag
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Medical Devices0 affectedFeb 10, 2025
High RiskFDA
Brainlab Ag
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Medical Devices56 affectedFeb 14, 2023
High RiskFDA
Brainlab Ag
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 I...
Medical Devices205 affectedFeb 25, 2022
High RiskFDA
Brainlab Ag
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients ...
Medical Devices22 affectedMay 14, 2021
High RiskFDA
Brainlab Ag
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: inten...
Medical Devices271 affectedAug 31, 2020
High RiskFDA
Brainlab Ag
Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)
Medical Devices21 affectedAug 20, 2020
High RiskFDA
Brainlab Ag
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
Medical Devices9 affectedJul 16, 2020
High RiskFDA
Brainlab Ag
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Medical Devices18 affectedJul 16, 2020
High RiskFDA
Brainlab Ag
Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2....
Medical Devices1,230 affectedSep 25, 2019
CriticalFDA
Brainlab Ag
Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine ...
Medical Devices148 affectedFeb 27, 2019
High RiskFDA
Brainlab Ag
ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a med...
Medical Devices587 affectedFeb 14, 2018
High RiskFDA
Brainlab Ag
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Medical Devices80 affectedNov 16, 2017
High RiskFDA
Brainlab Ag
BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 T...
Medical Devices28 affectedNov 3, 2017
High RiskFDA
Brainlab Ag
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applicati...
Medical Devices102 affectedJul 28, 2017
High RiskFDA
Brainlab Ag
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Medical Devices29 affectedOct 27, 2016
High RiskFDA
Brainlab Ag
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Medical Devices27 affectedMay 4, 2016
High RiskFDA
Brainlab Ag
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation...
Medical Devices48 affectedNov 5, 2015
High RiskFDA
Brainlab Ag
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation...
Medical Devices20 affectedNov 5, 2015
High RiskFDA
Brainlab Ag
Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consis...
Surgical Devices28 affectedAug 18, 2015
High RiskFDA
Brainlab Ag
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for st...
Medical Devices25 affectedMar 6, 2015
High RiskFDA
Brainlab Ag
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Medical Devices24 affectedFeb 16, 2015
High RiskFDA
Brainlab Ag
The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to ena...
Medical Devices114 affectedJan 16, 2015
High RiskFDA
Brainlab Ag
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radi...
Medical Devices1,412 affectedNov 19, 2014
High RiskFDA
Brainlab Ag
Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the dis...
Medical Devices154 affectedJun 27, 2014
High RiskFDA
Brainlab Ag
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimall...
Medical Devices17 affectedMay 21, 2014
High RiskFDA
Brainlab Ag
BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in ...
Medical Devices6 affectedJul 16, 2013
CriticalFDA
Brainlab Ag
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS Sys...
Medical Devices2,528 affectedApr 22, 2013